Balloon device for use in surgery and method of use

ABSTRACT

A balloon device useful for dissecting tissue or retracting tissue for the purpose of providing space for laparoscopic surgery comprising a balloon having at least two protuberances in its distal region. The present device is particularly useful in bladder neck suspension and hernia repair procedures.

RELATED APPLICATIONS

This is a continuation-in-part of application Ser. No. 08/570,766, filedDec. 12, 1995, now U.S. Pat. No. 5,772,680 the disclosure of which isincorporated herein by reference, which is a continuation-in-part ofapplication Ser. No. 08/403,012, filed on Mar. 10, 1995 now U.S. Pat.No. 5,540,711, which is a continuation-in-part of application Ser. No.08/388,233, filed Feb. 13, 1995 now U.S. Pat. No. 5,730,756, which is acontinuation-in-part of application Ser. No. 08/267,488, filed Jun. 29,1994 now U.S. Pat. No. 5,607,443, which is a continuation-in-part ofapplication Ser. No. 08/124,283, filed Sep. 20, 1993 now U.S. Pat. No.5,836,961, which is a continuation-in-part of application Ser. No.08/073,737, filed Jun. 8, 1993 now abandoned, which is a division ofapplication Ser. No. 07/893,988, filed Jun. 2, 1992 now U.S. Pat. No.6,312,442. My application Ser. No. 08/717,794, filed Sep. 20, 1996discloses a device of the type disclosed and claimed herein. Thedisclosure of each of these prior applications is hereby incorporated byreference in its entirety.

FIELD OF THE INVENTION

The present invention constitutes specially shaped balloon dissection orretraction devices and their use. The invention relates generally to anapparatus and method for developing an anatomic space for laparoscopicprocedures and, more specifically, to an apparatus and methodparticularly suitable for surgical procedures in which there is a needto dissect around an obstruction or around an area which it would beundesirable to dissect. The present invention provides a device whichcan be used to dissect around a hernia and in bladder neck suspensionprocedures, also known as urethropoxy, in which avoidance of the pubicsymphysis is desirable.

SUMMARY OF THE INVENTION

The present invention comprises a balloon suitable for tissue dissectionor tissue retraction which has at least two protuberances (which may bereferred to as “legs”, “arms”, “horns” or other descriptive term) at itsdistal region and its method of use.

These protuberances may be relatively large relative to the remainder ofthe balloon or they may be relatively small, depending upon the anatomyof the region in which the balloon is to be used. The purpose of theprotuberances is to achieve dissection in the desired location and toavoid dissection where it would be detrimental to the patient.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a diagrammatic view of an embodiment of this invention inwhich the protuberances are relatively large and are folded back intothe interior of the balloon in its deflated state.

FIG. 2 shows the balloon of FIG. 1 in a partially inflated state.

FIG. 3 shows the balloon of FIG. 1 in a fully inflated state.

FIG. 4 shows the balloon of FIG. 1 rolled on a guide rod.

FIG. 5 is a plan view of a balloon having an alternate shapecontemplated by the present invention.

FIG. 6 shows the balloon of FIG. 5 after it has been inflated to dissecttissue.

FIG. 7 is a perspective view of a balloon shaped according to thepresent invention together with inflation and tunneling means associatedtherewith.

FIG. 8 is a cross-sectional view of the balloon of FIG. 7.

FIGS. 9 and 10 illustrate still another embodiment of the presentinvention.

FIGS. 11A-11C illustrate the sequence of use of the device of thisinvention.

DETAILED DESCRIPTION OF THE INVENTION

The balloon devices described and claimed herein are suitable for thevarious uses disclosed in the parent and other applications identifiedherein which have been incorporated herein by reference. In connectionwith the present invention it has been found that in certain surgicalprocedures there is a need to dissect around an obstruction as forexample a hernia. For this purpose, a horseshoe-shaped or bifurcatedballoon 701, which is preferably nonelastic, e.g., made frompolyurethane or polyvinyl chloride, is provided as shown in FIGS. 1-4.The balloon 701 is substantially Y-shaped as shown in FIG. 3 and isprovided with a bifurcation which leads into legs 703 and 704 to providea U-shaped space therebetween. The balloon 701 can be constructed in themanner hereinbefore described for the previous balloons used inaccordance with the present invention.

The legs 703 and 704 can be folded back or inverted into the bifurcationas shown in FIG. 1 and then can be rolled into two rolls, rolled in fromopposite sides onto an olive-tipped guide rod 711 shown in FIG. 4 andheld in place by a separate balloon cover (not shown) or by the use offlaps forming a sleeve (not shown) to provide an assembly 712. It hasbeen found that in connection with the present invention to achieve thebest dissection capabilities for the balloon and expansion of theballoon, the balloon 701 is secured to the guide rod or tunneling rod711 so that the guide rod underlies the balloon. The side margins arerolled inwardly into two rolls so that the two rolls face downwardlytoward the tunneling guide rod 711. They are then brought into closeproximity with each other to form a single roll and secured to thetunneling guide rod 711 as hereinbefore described. A tubular member 713providing a balloon inflation lumen opening into the interior of theballoon 701 is sealed into the balloon 701. A Y adapter 714 is securedto the tubular member 713 and carries a male fitting 716 and anothertubular member 717 on which there is mounted a tubing clamp 718 andanother male fitting 719.

Let it be assumed that it is desired to dissect around an obstruction720 which by way of example can be ventral hernia or other obstructionthat cannot be readily dissected. Let it also be assumed that theassembly 712 shown in FIG. 4 has been introduced into a space with orwithout a laparoscope and an obstruction 720 is encountered and it isdesired to dissect around the obstruction 720. This can be accomplishedby removing the cover or sleeve (not shown) that was used for enclosingthe balloon 701 and securing it to the guide rod 711. As soon as theballoon 701 is released, it can be inflated through the tubular member713 to unroll sideways or laterally in a plane just proximal of theobstruction 720. The balloon 701, because of the manner in which it wasrolled up, will unroll downwardly and outwardly away from the tunnelingguide rod 711 to create the desired dissection. Continued inflation ofthe balloon will cause one or both the legs 703 and 704 to progressivelyevert and advance around the obstruction 720. Thus, as shown in FIG. 2,the arm 704 everts and passes around one side of the obstruction 720while accomplishing dissection as it goes, whereas the other arm 703 canthereafter or simultaneously evert to cause dissection around the otherside of the obstruction 720 until both of the legs 703 and 704 arecompletely inflated to create a dissection extending around theobstruction 720. The balloon 701 can then be deflated and removed. Thedissected space can then be insufflated and surgical procedures canthereafter be performed in the insufflated space. Alternatively, amechanical retractor, which may be, e.g., a toroidal balloon, may beused to maintain the dissected space in an “open” condition tofacilitate the surgical procedures.

Alternatively, as shown in FIG. 5, a balloon 1, preferably formed from anon-elastic material such as polyurethane or polyvinyl chloride, isprovided with protuberances 2 extending from the distal region of theballoon. Before inflation, the protuberances 2 are everted within theballoon 1 as shown by the dashed lines indicated by the referencenumeral 3. This permits the balloon 1 to be rolled or folded into acompact arrangement, e.g., around a substantially rigid tunneling memberhas shown in FIG. 7. As shown in FIGS. 5 and 6, the balloon may have acentral protuberance 5 or, as shown in FIGS. 7 and 8, the balloon mayhave no central protuberance. Furthermore, the central protuberance5,may be longer in axial dimension than shown in FIG. 5. In someembodiments, the central protuberance serves the purpose of facilitatingthe proper placement of a substantially rigid tunneling shaft in theballoon with the distal end of the tunneling shaft residing in thecentral protuberance, e.g., by passing the tunneling shaft throughpassage 6 in the balloon.

As shown in FIG. 6, once inflated, the balloon 1 has dissected the spaceof Retzius, but protuberances 2 have avoided dissection in a mannerwhich would risk damage to the pubic symphysis 9 or the medialneurovascular bundle 8. The pubic bones are indicated by the numeral 7and are connected by the pubic symphysis 8.

Balloons having the general shape shown in FIGS. 5-8 have been found tobe particularly efficacious for use in bladder-neck suspensionprocedures. Such procedures generally seek to elevate the urethrovesicaljunction (bladder neck) in order to restore more normal anatomy astherapy genuine urinary stress incontinence. The suspension is oftenaccomplished with sutures in the periurethral tissue to lift the bladderneck, but avoid damage to medial vasculature. Bladder-neck suspensionprocedures are now well known and are performed to correct femaleincontinence problems, particularly genuine stress incontinence. Thereare several recognized bladder-neck suspension procedures. One is the“Burch” procedure described by J. C. Burch in Am.J.Obstet.Gynecol. 1968;100:764-774 which was introduced in about 1955. Still earlier, Drs.Marshall, Marchetti and Krantz developed a bladder-neck suspensionprocedure which is disclosed in their article in Surg.Gyn.Obstet. 1949;88:509 and which has, because of the initials of these three doctors,become known as the “MMK” procedure. The disclosures of the aforesaidBurch and Marshall, Marchetti and Krantz articles are incorporatedherein by reference in their entireties. These bladder-neck suspensionprocedures elevate the urethra vesicular junction (“UVJ” or“bladder-neck”) in order to correct sagging of the bladder-neck. Whensuch sagging occurs, there is a reduction in the pressure retentioncapability of the urethra and related anatomy during moments of stresssuch as coughing, physical exertion and the like. This suspension isaccomplished with sutures on either side of the urethra which, in theMMK procedure pass through the periosteum of the pubic bone and, in aBurch procedure, through the periurethral tissue and Cooper's ligament.More recently, the MMK procedure has been modified to use bone anchorsin the pubic bone rather than the periostium as the site of one end ofthe suture connection. Such procedures are described in U.S. Pat. Nos.5,217,486; 5,207,679 and 4,899,743, the disclosures of which areincorporated herein by reference. Such procedures are also described inmy patent application Ser. No. 08/664,051, filed Jun. 13, 1996, thedisclosure of which is incorporated by reference herein.

The minimally invasive versions of these procedures require dissectionof the space of Retzius, which is a retropubic space and an inferiorextension of the preperitoneal space between the pubic symphysis and thebladder. Balloon dissection is a useful technique in this regard.Whenever balloon dissection is carried out in the preperitoneal space,it is advantageous if Cooper's ligament is at least partially denuded byexpansion of the balloon itself. Before Cooper's ligament is exposed,there are few landmarks to orient the surgeon and he must proceed withcareful manual dissection as he creates his working space. In contrast,if Cooper's ligament is exposed by the balloon, its white appearanceprovides an immediate landmark for the surgeon, his orientation isimmediate, and tedious manual dissection is reduced or eliminated.

In the inferior anatomy, there are important structures which must berespected during dissection. In addition to the bladder itself, thereare important vascular and nerve complexes both medial and lateral, atthe level of and inferior to the pubis. It is therefore important thatthe balloon means, although inherently gentle, minimize trauma to thesestructures, but still accomplish sufficient safe dissection to affordvisualization if needed, provide access to Cooper's ligament between themedial and lateral vessels for suture attachment, and promote scarringand hence adhesions to reinforce the suture suspension post-operatively.

This invention provides for two inflatable extensions distal of the mainbody of the balloon which may optionally be inverted, folded, or rolledindependently of the main body of the balloon. If inverted, thecross-sectional aspect of the extensions may be sized to assuresequential inflation after the main body of the balloon is inflated. Inthis manner, the main body can be made to act as an anchor from whichthe extensions may extend in a controlled manner. If spacedappropriately, the extensions will dissect a safe area between delicatemedial and lateral structures quite effectively. Independently, the mainbody of the balloon may be shaped to suit the surgeon preference orprocedure.

The balloon 1 may have an elongate neck such as that indicated byreference numeral 4 and may be utilized with any of the variousembodiments of tunneling apparatus disclosed in application Ser. No.08/570,766, filed Dec. 12, 1995, which is incorporated herein byreference.

FIG. 7 illustrates a balloon 87 configured according to the presentinvention. Balloon 87 is preferably formed of a non-elastomeric, medicalgrade material of a suitable type such as polyvinyl chloride orpolyurethane. Balloon 87 can be formed of two sheets, 88 and 89, of suchmaterial which have their outer margins bonded together by suitablemeans such as by heat at margin 91 extending around the parameter ofballoon 87. Alternatively, balloon 87 may be a single molded piece.

Balloon 87 is also provided with neck 94 into which flexible tubularmember 96 extends. Tubular member 96 is secured to balloon 87 in asuitable airtight fashion, such as by an adhesive. The tubular member 96is provided with a lumen 97 which is in communication with the interiorof the balloon 87 and which can be used for inflating balloon 87 througha Luer-type fitting 98 mounted on the tube 96.

Means are provided for removably securing balloon 87 to tunneling shaft47, such as by sleeve 101 formed of the same material as balloon 87, andwhich can be formed integral or separate therefrom and adhered theretoby suitable means such as an adhesive. The sleeve 101 extendslongitudinally of the balloon 87 and is typically, but not necessarily,disposed generally equidistant from the side margins thereof. The sleeve101 is provided with passage 102 extending therethrough which is sizedto slidably accommodate the tunneling shaft 47. Means are provided forpermitting separation of balloon 87 from the tunneling shaft 47 and maytake the form of longitudinally spaced apart perforations 103 in sleeve101 extending along sleeve 101. Perforations 103 are spaced closelyenough together to form a weakened region so that the balloon canreadily be separated from the tunneling shaft 47 by tearing alongperforations 103 in sleeve 101. The distal portion of sleeve 101 can beprovided with means, e.g., a radially extending ridge, which will createa tighter fit with shaft 47 and inhibit axial movement of balloon 87when a removable sleeve (not shown) is withdrawn.

As shown in FIG. 8, which is a cross-sectional view taken along line 8—8of FIG. 7, when balloon 87 is deflated, its side margins can be rolledinwardly toward tunneling shaft 47 as shown by the broken lines in FIG.8. When in its rolled-up configuration, balloon 87 can be enclosedwithin a removable sleeve (not shown) which comprises a cylindrical tubeas shown, e.g., in application Ser. No. 08/717,794, filed Sep. 20, 1996,which is incorporated herein by reference.

In the embodiments described above, insertion of the dissecting devicetowards the space of Retzius generally proceeds inferiorly from near theumbilicus. However, it is not unusual that a female, by the time shepresents with genuine stress incontinence, has experienced previousabdominal procedures, caesarean childbirth, or other abdominal trauma tomake an umbilical approach difficult, if not impossible because ofscarring. At the very least, penetration through the peritoneum islikely. In cases of scarring, as shown in FIG. 9, a Pfannenstiel scarincision (11) is perhaps the most inferior type of scar likely to beencountered. These are transverse about the midline, and generally 3 to5 cm above the pubis. They impede the tunneling of a balloon dissectorfrom the umbilicus.

With some bladder neck procedures it may not be necessary to developworking space above the Pfannenstiel scar in order to carry out theprocedure. A balloon dissector 13 can be inserted through a lateral cutdown 12 just inferior to the Pfannenstiel scar, and can be tunneledlaterally just below the scar to the other side, taking care to stayanterior to the peritoneum. The balloon can then be inflated. If shapedto open esentially to the inferior side only, a space from thePfannenstiel scar downwards can be developed.

After dissection, the urethropexy can proceed. In many instances, thisinferior space may be more convenient than one developed from a moresuperior incision.

A suitable balloon for the purpose of dissection inferior to aPfannenstiel scar is as shown in FIG. 10. It is asymmetrical about thetunneling number 14, and has horns 15. As described above, these may beinverted for sequential deployment, or they may merely be rolled orgathered adjacent to the tunneling member. A balloon cover, aspreviously described and referenced will facilitate tunneling of thedevice, and positioning such that the larger side will deployinferiorly. On inflation, the dissected space below the scar will besimilar to the inferior portion of the device described above which istunneled from the umbilicus.

The sequence of balloon introduction on a tunneling shaft 79, inflationof the balloon 87 and inflation of the protuberances 88 is shown inFIGS. 11A, 11B and 11C. The patient is prepared in an appropriate mannerby administering a suitable anesthesia, as for example a spinalanesthesia, and any other necessary preparation. The surgeon first makesan infraumbilical incision 126 in the skin below the navel or umbilicus127 and separates the fat 129 and then incises the anterior rectussheath or fascia 131 in the midline. Care should be taken not topenetrate the peritoneum 132 overlying the abdominal cavity 133 (seeFIG. 11A).

After the incision 126 has been made in the manner hereinbeforedescribed, the laparoscopic apparatus 31 is then taken by one hand ofthe surgeon, grasping the handle 56 and utilizing the other hand tofacilitate the insertion of the rounded blunt tip 79 into the incision126. The blunt tip 79 is caused to enter the slit in the fascia 131 andpass anterior to the peritoneum 132, in between the rectus muscles(laterally), and enters the potential preperitoneal space 136. The blunttip 79 is then utilized as a tunneling device by the surgeon using onehand 56 to advance the blunt end 79 toward the pubic region of thepatient while the surgeon places his other hand on the abdomen to feelthe apparatus or device 31 as it is being advanced. The advance of thedevice 31 is continued until the blunt tip 79 is below the symphysispubis 137 as shown in FIG. 11B, and preferably is disposed between thesymphysis pubis 137 and the bladder 138.

After the apparatus or device 31 has been properly positioned as shownin FIG. 11B, the removable sleeve or sheath 106 is removed by thesurgeon using one hand to engage the proximal portion of device 31 whichis exterior of the body of the patient and outside of the incision 126.At the same time, the other hand of the surgeon is utilized to stabilizethe portion of the device 31 which is within the preperitoneal space.The sheath 106 can be readily withdrawn since it is formed of Teflon andis split or weakened along its length, by pulling it proximally and awayfrom the longitudinal axis of the tubular member 33. As the sheath 106opens and slips off, it exposes the balloon 87 of the balloon assembly86. When the sheath 106 is completely removed, a sterile saline solutionserving as a balloon inflation medium is introduced into the balloon 87through the tubular member 96 by connecting a conventional syringe 141to the Luer fitting 98. The balloon 87 typically can be inflated to asuitable size by introducing 500 cc or less of normal saline solutioninto the balloon 87 by pressing on the plunger 142. As the balloon 87 isinflated, the balloon 87 progressively unwraps with its side marginsrolling outwardly from the center while expanding into a plane to causeprogressive separation or dissection of tissue (i.e. 131, 132) along itsweakest points by application of forces generally perpendicular to theplane of the balloon 87 as to create the peritoneal or anatomic space.

As shown in FIG. 11C, further inflation of the balloon causesprotuberances 88 to inflate around the pubic symphysis withoutdisrupting it.

After the desire bloodless anatomic space or pocket 136 is formed, theballoon 87 is deflated by withdrawing the normal saline solution bywithdrawal of the plunger 142 of the syringe 141 or via a hospitalvacuum aspirator. After the balloon 87 has been deflated, the balloonassembly 86 can be removed by grasping the handle 56 of the laparoscopicapparatus or device 31 with one hand and using the other hand to graspthe tubular member 96 and the proximal extremity of the balloon 87 andto remove the same through the incision 126. Bladder neck suspension canthen be performed as described above.

A suitable material for fabrication of the balloon of the presentinvention is 0.004 inch thick polyurethane film such as PS-8010 suppliedby Deerfield Urethane, Inc. of South Deerfield, Mass.

From the foregoing, it can be seen that the apparatus and methods of thepresent invention can be utilized in connection with variouslaparoscopic surgical procedures and in particular with bladder necksuspension procedures. While embodiments and applications of thedisclosed devices and associated methods have been shown and described,it will be apparent to those skilled in the art that the foregoingspecific embodiments can be modified without departing from the scope ofthe present invention. Thus, the present invention is of the full scopeof the claims appended hereto.

I claim:
 1. A balloon device for use in laparoscopic surgery comprising:a balloon mounted on a tunneling shaft and having a main body with aproximal end, a distal end, and at least two inflatable invertedprotuberances in the distal end, said protuberances configured to evertoutwardly sequentially and away from the proximal end after said mainbody inflates via an inflation lumen, each protuberance having aninflation axis, the inflation axes being parallel to each other, whereinsaid balloon, when deflated, is rolled-up and adjacent to said tunnelingshaft.
 2. A balloon device for use in laparoscopic surgery comprising: adeflated balloon having a main body, and at least two protuberances withrounded ends and positioned on one side of the main body, and atunneling shaft to which the balloon is asymmetrically attached, saidtunneling shaft having a longitudinal axis, wherein when said balloon isinflated via an inflation lumen, said at least two protuberances extendalong parallel first and second inflation axes in a direction which issubstantially transverse to the longitudinal axis of said tunnelingshaft, and wherein said first inflation axis combined with saidlongitudinal axis, said second inflation axis combined with saidlongitudinal axis, and the main body combined with said longitudinalaxis form substantially the same plane.
 3. The device of claim 2 whereinsaid balloon is attached to said tunneling shaft such that one side ofsaid balloon is attached to said shaft.
 4. The device of claim 2 whereinsaid at least two protuberances are inverted and evert outwardly whensaid balloon is inflated.
 5. The balloon device of claim 2, wherein themain body of the balloon comprises a first side and a second side, theat least two protuberances being positioned on the first side, and thetunneling shaft being positioned substantially adjacent the second side.6. A balloon device for use in laparoscopic surgery comprising: aballoon having at least two protuberances positioned on one side of saidballoon, wherein said at least two protuberances are adapted tosequentially deploy as said balloon is inflated via an inflation lumen,a tunneling shaft to which the balloon is attached, said tunneling shafthaving a longitudinal axis, wherein said protuberances sequentiallydeploy along parallel first and second inflation axes in a directionwhich is substantially transverse to the longitudinal axis of saidtunneling shaft, and wherein said first inflation axis combined withsaid longitudinal axis and said second inflation axis combined with saidlongitudinal axis form substantially the same plane.
 7. A balloon devicefor use in laparoscopic surgery comprising: a deflated balloon mountedon a tunneling shaft and having a main body and at least two inflatableprotuberances in its distal region that inflate along parallel inflationaxes via an inflation lumen, wherein prior to inflation of said balloon,said main body and said at least two inflatable protuberances of saidballoon are rolled up and adjacent to said tunneling shaft, and saidprotuberances inflate sequentially after said main body.
 8. A balloondevice for use in laparoscopic surgery comprising: a deflated balloonhaving a main body with a distal end, a proximal end, and at least twoinflatable inverted protuberances in the distal end, said at least twoinflatable inverted protuberances everting outwardly sequentially, awayfrom the proximal end, and along parallel inflation axes, after saidmain body when said balloon is inflated via an inflation lumen, whereinsaid balloon is mounted on a tunneling shaft and said deflated balloonis rolled-up and adjacent to said tunneling shaft.